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Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Oropharyngeal Cancer, Hypopharyngeal Cancer

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Trial Information

Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx


Locoregionally advanced squamous cell carcinoma of the head and neck(LA-SCCHN) poses one of
the most complex management challenges. This stage of disease is still potentially curable,
but requires combined-modality therapy. Recent studies have showed that induction
chemotherapy(neoadjuvant)reduced the 3-year distant relapse rate. Concurrent
chemoradiotherapy(CCRT), on the other hand, has demonstrated a significant and consistent
benefit in local control rates, but its impact on distant failure is inconsistent.
Nimotuzumab is a novel EGFR-targeting monoclonal antibody that has the potential.to be used
as a single agent or as a radio- and chemotherapy sensitizer for the treatment of SCCHN.
Thus, investigators conducted a randomized, multicenter phaseⅡ study to compare the
efficiency and safety of adding nimotuzumab to neoadjuvant and CCRT with neoadjuvant and
CCRT in the treatment of patients with locoregionally advanced squamous cell carcinoma of
the oropharynx and hypopharynx.


Inclusion Criteria:



- Informed consent form

- Histologically confirmed locally advanced (stages III and IVb), squamous cell
carcinoma of the oropharynx and hypopharynx

- The tumor mass had to be measurable

- Karnofsky performance status ≥70

- Life expectancy estimated than 6 months

- Hematologic: WBC≥4×109 /L , plateletes≥100×109 /L, haemoglobin ≥100 g/L;

- Hepatic: AST/ALT<1.5 times upper limit of normal (ULN);serum bilirubin<1.5 times ULN;

- Renal: Creatinine<1.5 times ULN;

Exclusion Criteria:

- Known distant metastases

- Primary tumor and nodes received surgery(except of biopsy)

- Received other anti EGFR monoclonal antibody treatment

- Previous chemotherapy or radiotherapy

- Participation in other interventional clinical trials within 1 month

- Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of
cervix)

- History of serious allergic or allergy

- History of Serious lung or heart disease

- Pregnancy or lactation women, or women with suspected pregnancy or men with willing
to get pregnant

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Description:

Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.

Outcome Time Frame:

3 months after all the treatment ending

Safety Issue:

No

Principal Investigator

Yi J Lang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiotherapy department

Authority:

China: Food and Drug Administration

Study ID:

BT-IST-SCCHN-036

NCT ID:

NCT01516996

Start Date:

March 2012

Completion Date:

March 2018

Related Keywords:

  • Oropharyngeal Cancer
  • Hypopharyngeal Cancer
  • Neoadjuvant
  • Concurrent Chemoradiotherapy,CCRT
  • Nimotuzumab
  • Locoregionally Advanced Oropharynx
  • Hypopharynx cancer
  • Randomized
  • Multicenter
  • Carcinoma, Squamous Cell
  • Oropharyngeal Neoplasms
  • Hypopharyngeal Neoplasms

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